The
FDA is on a rampage. One of FDA Commissioner Margaret A. Hamburg’s
first acts was to reverse a Bush administration policy that forbad FDA
district offices from taking unilateral enforcement action against a
regulatee without first obtaining the consent of the FDA Chief Counsel’s
office. The message Hamburg has sent to her legions is clear: go on
the march and enforce FDA regulations with zeal. Within the agency bureaucrats
frustrated by funding limitations and management directions to avoid
action except in cases of perceived necessity are flush with new money
and are making up for lost time. Dr. Hamburg wants to be known as the
FDA Enforcer.

This
comes not only at a time of national recession but also at a time when
FDA has assumed new powers over the dietary supplement industry. The
FDA Good Manufacturing Practice Guidelines for dietary supplements are
over 1,000 pages of new regulations that give FDA broad new discretionary
enforcement powers. So loosely worded are these regulations that it
is impossible for any regulatee to know whether he or she is in compliance
with them. An FDA investigator is free to find violations, and every
violation is deemed by operation of law “adulteration” whether
it involves a risk to human health or not. The rules are worded in a
manner that would please Lao Tzu, Grand Councilor in the ancient state
of Chin (the warring state of China that defeated all other warring
states and unified the country under one emperor, Qin Shi Huangdi).
Tzu believed that you should punish light crimes severely. By doing
so, he believed there would eventually be no serious crimes. He also
believed there were only two legitimate pursuits, agriculture and warfare,
so all other occupations were to be made so burdensome through taxation
and punishments that all would be drawn to laboring in the fields and
to martial arts. He had edicts regulating behavior posted on high poles
beyond the visual spectrum of most, causing almost all to violate the
law from time to time out of ignorance. Those who violated the law were
punished severely, often with corporal punishment, including severing
of limbs.

Like
Tzu, Hamburg appears to believe that she must punish light crimes severely.
Rule violations that entail no actual harm to the public now carry with
them severe regulatory rebukes. Daily the FDA press office generates
news of its onslaught. The focus is not on arresting violations that
cause harm but on punishing all violators, even those who have violated
the law unwittingly and have done so in ways that have caused no demonstrable
harm.

The
effect is an extraordinary imposition of federal might on tender economic
shoots. Small and medium sized companies in the food and supplement
industries are feeling for the first time the mighty weight of an angry
federal government. Whole product categories and claims are being driven
from the market largely without judicial recourse. Few companies wish
to risk the wrath of the agency because the agency can retaliate by
conducting inspection after inspection, taxing the company’s resources
beyond the breaking point. Few have the financial wherewithal to fight
the agency in court, and the courts defer to agency enforcement with
great regularity so they offer little hope of relief.

Effectively
condemned without a trial, small regulated businesses bend to the FDA’s
wishes and pray for the chance to remain in business. “When the
people fear their government,” said Thomas Jefferson, “there
is tyranny; when the government fears the people, there is liberty.”
No one in the food and dietary supplement industries thinks the government
fears them; rather, they are terrified of their government. They are
beginning to understand the true definition of tyranny.

There
are grave consequences that arise from Dr. Hamburg’s enforcement
campaign. For every company she sacks, there are employees who become
unemployed. For most of them, there are children at home dependent on
the income who suddenly suffer. The federal wrecking ball Hamburg wields
is destroying the life’s blood of the economy, small business
after small business. Consumers too are denied access to goods, some
of which reduce the incidence of disease or provide comfort or convenience.
There is little concern for their welfare when a technical rule violation
leads to a loss of desired consumer goods.

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There
is a gross disparity in this enforcement. With rare exceptions large
companies, including pharmaceutical companies that hold FDA captive
(yes, FDA fears those companies, so for them there is liberty), escape
the agency’s wrath. For sure there have been some remarkable slaps
given the pharmaceutical industry, but no take downs—no storming
of the offices with U.S. Marshals, FDA agents, and DEA agents like they
do to so many little guys. In most instances a single letter telling
the parties in question of their law violations and demanding that they
stop would suffice to end the law violations, but that would grab few
headlines. To be perceived as the enforcer, Dr. Hamburg needs her press
office to report on the exertion of raw federal power against the hapless
supplement or food company.

To
be sure there are instances where federal power should come to the rescue.
Those involve direct threats to public health (e.g., the sale of contaminated
food stuffs or drugs), but use of draconian measures against those whose
violations do not threaten public health or against those all to willing
to heed federal commands without a jack boot is economically destructive.

Before
Dr. Hamburg has unleashed federal forces, she has not performed a single
calculation of the costs of imposing force. How much federal force can
the fragile economy, and this sector of the economy, take? That question
is not evaluated. If the enforcement effort destroys 10,000 or 100,000
jobs; if it ruins an entire industry sector; if it creates an anti-competitive
benefit for one industry over another—none of that matters to
the leader of this agency.

Indeed,
few people on earth enjoy the unbridled power of the FDA Commissioner.
She rules over 20% of the American economy, effectively the entire drug,
medical device, food, dietary supplement, and cosmetic markets. With
an utterance, she can make a company or a market sector fabulously wealthy
overnight and she can likewise crush into oblivion any company. Her
powers are thus tyrannical. Day to day she experiences virtually no
oversight. In bed with pharmaceutical company interests, Congress cares
little for what Dr. Hamburg does except when it threatens those interests
upon whom members depend to enrich their campaign coffers and provide
them with employment after government service. The President is pleased
to let Dr. Hamburg have free reign. The courts largely defer to the
agency, except in exceptional cases. She is the most powerful governing
force affecting the health care market in the United States yet she
is largely unaccountable to the President, the Congress, the courts,
and the American people. She is unelected.

The
FDA is not an isolated case. Other federal agencies, the EPA, the DEA,
the CPSC, the BLM, among many others, have likewise received new grants
of authority to recommence enforcement. It is as if tens of thousands
of battle tanks low on fuel and in need of spare parts have been refueled
and retooled to lay waste to industries across the country, the very
industries whose tax dollars finance the construction and operation
of those tanks.

This
bureaucratic enforcement not in cases of necessity but in all cases
comes at a time when lessening of bureaucratic strictures is essential
to the survival and growth of beleaguered small and medium sized businesses.
The effective tax these enforcement efforts have on the economy is enormous
and will retard small business growth for decades. Economic recovery
and a return to near full employment depends on ease of entry into markets
and on flexibility needed to grow and compete. In a federal world that
contains a complex of regulation so immense that no one, literally no
one, can confidently say that his or her business is in full compliance,
strict enforcement of the law leads to the obliteration of that engine
of recovery upon which this nation depends, small business.

If
economic recovery is to occur in the short-term and be sustainable,
there must be a roll-back of federal regulation, a refocus to unleash
federal forces only against those whose transgressions threaten actual
injury, and a commitment to use less draconian means in every instance
where a warning can achieve law compliance without imposing economic
injury. That common sense approach escapes the minds of those who care
little for markets but much for their own power and prestige as regulators.

As
new federal enforcement lays waste to small and medium sized businesses
across the country, we should remember who is to blame for the destruction
of American liberties and free enterprise. America will not regain its
prominence as an economic giant unless it returns to a deregulatory
agenda, humbles those in power, and unleashes the free market.

Jonathan
W. Emord is an attorney who practices constitutional and administrative
law before the federal courts and agencies. Congressman Ron Paul calls
Jonathan “a hero of the health freedom revolution.” He has
defeated the FDA in federal court a remarkable six times, four times on
First Amendment grounds. He is the author of The
Rise of Tyranny.

There
are grave consequences that arise from Dr. Hamburg’s enforcement
campaign. For every company she sacks, there are employees who become
unemployed. For most of them, there are children at home dependent on
the income who suddenly suffer.